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Regulatory Publisher Jobs (NOW HIRING)

Cardinal Health

Perform advanced document quality control, formatting, and publishing in compliance with global regulatory standards using tools such as MS Office and Adobe Acrobat. * Mentor and provide day-to-day ...

Ardelyx

Regulatory Systems Manager

Newark, CA · On-site

$117K - $143K/yr

Serve as the primary business owner and administrator for regulatory systems (e.g. regulatory information management systems, document management systems, and submission publishing tools) * Manage ...

Ardelyx

Regulatory Systems Manager

Newark, CA

$117K - $143K/yr

Serve as the primary business owner and administrator for regulatory systems (e.g. regulatory information management systems, document management systems, and submission publishing tools) * Manage ...

Ardelyx

Regulatory Systems Manager

Newark, CA

$117K - $143K/yr

Serve as the primary business owner and administrator for regulatory systems (e.g. regulatory information management systems, document management systems, and submission publishing tools) * Manage ...

Ardelyx

Regulatory Systems Manager

Newark, CA

Serve as the primary business owner and administrator for regulatory systems (e.g. regulatory information management systems, document management systems, and submission publishing tools) * Manage ...

Ardelyx

Regulatory Systems Manager

Newark, CA

$117K - $143K/yr

Serve as the primary business owner and administrator for regulatory systems (e.g. regulatory information management systems, document management systems, and submission publishing tools) * Manage ...

Codera

Director, Regulatory Affairs

San Diego, CA · Remote

... publishing and management of content in applicable information systems. This position proactively ... Provide regulatory strategy advice and support the development and execution of regulatory ...

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How much do regulatory publisher jobs pay per hour?

As of Jun 11, 2026, the average hourly pay for regulatory publisher in the United States is $39.57, according to ZipRecruiter salary data. Most workers in this role earn between $31.73 and $46.88 per hour, depending on experience, location, and employer.

What are some typical challenges a Regulatory Publisher might face in their daily work?

Regulatory Publishers often encounter tight deadlines and frequently changing regulatory requirements, which can make prioritizing tasks and staying up-to-date a challenge. Managing complex submissions that involve compiling, formatting, and validating large volumes of documentation requires both technical and organizational expertise. Additionally, close collaboration with regulatory affairs, medical writers, and quality assurance teams is essential to ensure submissions are accurate and compliant. Overcoming these challenges involves a keen attention to detail, adaptability, and strong communication skills, all of which are highly valued in this role.

What does a Regulatory Publisher do?

A Regulatory Publisher is responsible for compiling, formatting, and submitting regulatory documents to health authorities, ensuring compliance with global submission standards such as eCTD (Electronic Common Technical Document). They work closely with regulatory affairs teams to prepare dossiers for drug approvals, variations, and renewals. Their role involves quality control, document troubleshooting, and staying up to date with regulatory submission requirements. Effective use of publishing software and strict adherence to guidelines are essential for ensuring successful submissions.

What are the key skills and qualifications needed to thrive in the Regulatory Publisher position, and why are they important?

To thrive as a Regulatory Publisher, you need a thorough understanding of regulatory submission requirements, document management, and attention to detail, typically supported by experience in the pharmaceutical or biotechnology industries. Proficiency with electronic submission tools such as eCTD publishing software (e.g., Lorenz DocuBridge, Extedo), and familiarity with FDA or EMA guidelines, are highly valued. Strong organization, effective communication, and the ability to manage multiple projects simultaneously are important soft skills. These abilities are vital for ensuring timely, compliant submissions and efficient collaboration across regulatory and project teams.

More about Regulatory Publisher jobs
What cities are hiring for Regulatory Publisher jobs? Cities with the most Regulatory Publisher job openings:
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What job categories do people searching Regulatory Publisher jobs look for? The top searched job categories for Regulatory Publisher jobs are:
Regulatory Publisher jobs near you
Infographic showing various Regulatory Publisher job openings in the United States as of June 2026, with employment types broken down into 1% As Needed, 96% Full Time, and 3% Contract. Highlights an 91% Physical, 3% Hybrid, and 6% Remote job distribution, with an average salary of $82,307 per year, or $39.6 per hour.
Regulatory Affairs Manager

Regulatory Affairs Manager

Technical Resources International, Inc

Bethesda, MD • On-site

Full-time

Posted 2 days ago

Job description

Job Title
Regulatory Affairs Manager
Location
Bethesda, MD 20817 US (Primary)
Category
Regulatory Affairs
Job Type
Full-Time
Salary Range
100,000.00-120,000.00/YEAR
Education
Bachelor's Degree
Travel
None
Job Description
  • Manages Regulatory Team(s) to manage the lifecycle of multiple drug and biologic Investigational New Drug Applications (INDs), Biologics License Application (BLAs), New Drug Application (NDAs), Investigational Device Exemption (IDEs), and to ensure compliance in accordance with GCPs/ICH and all applicable FDA/other Regulatory Health Authority regulations.
  • Coordinates the tracking, compiling, and reviewing of regulatory submissions including, but not limited to New INDs, BLA, NDS, IDEs, Annual Reports to INDs and Protocol Reviews for accuracy, completeness and quality.
  • Works closely with project management to mitigate/resolve issues and/or deviations from target timelines.
  • Supervises and manage Regulatory Team staff members, as assigned.
  • Leads and participates in projects as assigned to optimize regulatory processes and facilitate best practice approaches to drive functional excellence.
  • Effectively engage in high-profile communications and interactions with colleagues, collaborators, clients, regulatory health authority staff, and pharma staff as appropriate.
  • Coordinates the maintenance of work process tools to promote efficiency and productivity.? These may include templates, SOPs, work instructions, checklists, trackers, etc.
  • Performs literature searches, attend meetings, etc. as needed to support regulatory document preparation, regulatory intelligence, and regulatory strategy, and to stay current with applicable therapeutic areas of clients.
  • Provides regulatory and project management support for projects as needed.
  • Coordinates across projects as needed to ensure harmonization and knowledge sharing.
  • Provides oversight for the tracking of regulatory activity, database maintenance, and ensure that records are complete, accurate, and current.
  • Supports the preparation and review of technical proposals.

Job Requirements
  • Excellent oral and written communication skills; detail-oriented and able to multi-task/prioritize well.
  • Strong management and leadership skills; experience leading/managing a team/project and/or supervising staff preferred.
  • Superior organizational skills and customer service abilities.
  • Ability to analyze medical research data and review experimental protocols.
  • Strong working knowledge of Microsoft office; experience with SharePoint a plus.
  • Professional or educational background in a scientific field, clinical trials, regulatory affairs or health care; familiarity with GCP and/or experience working in an FDA-regulated environment is desirable. General knowledge of the drug/vaccine development process or clinical trials is a plus.
  • Experience in preparing regulatory documents, publishing regulatory submissions using?electronic publishing software and proficiency in preparing documents that are compliant with electronic submission standards.
  • Must be able to exercise initiative and sound judgment, and to prioritize ongoing projects.?

We are equal opportunity/affirmative action employers, committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status, or any other protected characteristic under state or local law.

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